Approval rate for biologics drop in India

To support the R&D, which is taking place in drug discovery, to over coming the failures in selecting the target candidate molecules for clinical trials, many companies with back ground in science, technology and mathematics have been developing tools. Strand Life Sciences, the first company in India to start its operation in bioinformatics space in 2000 in Bangalore has developed many tools and later added additional features to the same for providing value addition to the tools. In 2012, Strand launched Hepatotoxicity Prediction Platform a novel systems approach to model pathways in the liver and combined it with in vitro measurements to create a detailed predictive platform. The platform is capable of providing insight into Drug Induced Liver Injury (DILI). This unprecedented approach will help in replacing or reducing animal usage, and increase efficiency of drug development by predicting hepatotoxicity.

Similarly V Life Sciences from Pune has launched ViTAL (VLife Toxicity Alerts) that can predict the genotoxic potential of a compound based on identification and significance of structural alerts. The product will help the companies to assess the genotoxic potential of new products, especially while entering into regulated markets as regulatory authorities and regulations like EMEA, EDQM, USFDA, REACH etc. provide guidelines on threshold of toxicological concern and safe, acceptable limits of genotoxic impurities associated with the active pharmaceutical ingredient.BioAxis from Hyderabad has come up a repository of tools, bio-softwares, research protocols and packages which offer a wide range of solution in the multidisciplinary area of life science research. It is equipped with routinely used molecular biology, microbiology, immunological needs and other requirements like DNA, RNA and protein sequence annotation and identification to the fully loaded working environments of microarray data analysis and deep sequencing.

Bangalore based Polyclone Bioservices has introduced ePep, a comprehensive web-based tool developed for designing peptides with chemical modifications and analyzing different properties of peptides. ePep calculates 35 different properties of a peptide which are classified into six broad categories and provides graphical overviews of the results in the same webpage.ePep also enables 69 different chemical modifications that can be incorporated with a user friendly interface.

While some companies are focussing on developing platform, tools, systems, a few others have focussed on building a proper database. Molecular Connections has started offering MCPaIRS (Molecular Connections Patent Information Retrieval System), the first Indian Patent Full Text Database with Legal status. The data is hand-curated by domain experts and provided in an easy to use web interface for use by patent analysts, attorneys and IP departments of the world. MCPaIRS contains full texts of granted patents and published applications, and may customizable.

The bioinformatics tools, diagnostic and biopharma products launched this year, are all set to directly impact the general public since they are focused on India specific issues. An innovative dengue testing kit, a indigenously developed and manufactured Japanese encephalitis, a platform diagnostic for a wide variety of pathogens are just some of the novel solutions for disorders prevalent in this geography.